1. Field of Invention
This invention relates to a lateral flow strip assay system and uses thereof. In particular, the present invention relates to lateral flow assay systems for the simple and inexpensive detection of biomolecules.
2. Description of Related Art
The invention provides for rapid response immunoassay testing through lateral flow immunochromatographic assays of a specific antigen that is present in human or animal fluids with an audio and visual result of the test and when needed, an electronic surge to provide heat for rapid results. The present invention can be adapted for an ever growing range of tests for the clinical, veterinary, agricultural, food industry, bio-defense and environmental applications. Fluids include, but are not limited to, aqueous and/or solvent extraction solutions and/or suspensions, enrichment media, saliva, urine, blood and sweat.
The invention provides for a digital reader that provides the user with both a visual and an audio result. An example of this would be the determination of pregnancy. The pregnancy device would include conventional sensors to provide the user with a color band that appears or is absent when a specific antigen is present in a human fluid such as detecting chorionic gonadotropin (hCG) in urine. The speed of result can be increased with the electronic surge generated by a battery driven circuit to the sample. The result can then be visually read and/or revealed through audio means whereby the unit announces “Congratulations You Are Pregnant” or “I'm sorry you are not pregnant, better luck next time”. The result can also be coupled with a fluorescent dye conjugate and read on a fluorescence reader. A device coupling lateral flow with the sensitivity of fluorescence would exhibit increased sensitivity.
The manufacture of the present invention can include, but is not limited to, plastic components, or as a continuous substrate as described in the embodiments of U.S. Pat. No. 5,965,848.
The present invention provides for a unique and novel, inexpensive, user friendly, optionally, disposable and/or recyclable, device for an already proven technology of lateral flow with the added aspect of electronic surge to provide the sample with a rapid test result that be can heard as well as seen.
Current lateral flow devices often require use of an incubator, or other extrinsic heating device, in order to get an accurate result. One exemplary advantage of the device of the invention is that the heating element is, for example, built in to the device. In one embodiment, the device of the invention is thus portable, and no extrinsic heating is necessary.
The invention can be produced to test for a variety of biological elements including but not limited to: infections diseases, such as influenza, strep, HIV, measles, rotavirus, typhoid, hepatitis; drugs of abuse, such as cocaine, heroin, pain killers, cocaine, methamphetamine and other drugs; hormones such as HcG, estrogen, cortisol; clinical indications, such as pregnancy, prostatic acid phosphatase, various tumor markers, cholesterol, glucose, and cancer markers; therapeutic drug monitoring of drugs such as, theophylline, aminoglycoside antibiotics (gentamicin), antiepileptics (such as carbamazepine, phenyloin, and valproic acid), mood stabilizers, especially lithium citrate, antipsychotics (such as pimozide and clozapine). The device of the invention may comprise, for example, temperature control and/or on-board mixing as an aid in viscosity control of the reaction, to ensure better accuracy and precision.
All references cited herein are incorporated herein by reference in their entireties.